FDA 483 - Sol-Millennium Medical Inc. - December 20, 2023

Sol-Millennium Medical Inc. in Chicago, IL, was cited for significant deficiencies in its quality system, particularly concerning design change control, medical device reporting (MDR), and complaint handling. The inspection revealed instances where products were marketed without proper 510k clearance, serious adverse events were not reported, and complaint investigations lacked required information like UDIs. These issues indicate a systemic failure to ensure the safety and regulatory compliance of their medical devices.